Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.

Painful Diabetic Neuropathy Clinical Trial

Official title:

A Multi-center, Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546351
• Other study ID #: SP0746
• Secondary ID: 2004-000551-42
• Status: Completed
• Phase: Phase 3
• Start date: May 2004
• Est. completion date: January 2011

Study information

• Verified date: August 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 621
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects who completed Study SP743 (NCT00238524) or SP874 (NCT00350103) and, in the investigator's opinion, might benefit from long-term administration of SP746 (NCT00546351). Exception: subjects who prematurely discontinued
• SP743 (NCT00238524) or SP874 (NCT00350103) due to lack of efficacy or due to intolerability to trial medication (after Visit 5but prior to entering the Maintenance Phase) may be eligible to participate in SP746 (NCT00546351), after consultation with the medical monitor

Exclusion Criteria:

• Subject has clinically relevant ECG abnormalities, or a QTc interval =500 ms, and/or a QTc interval increase of =60 ms from the mean pre-dose QTc value at Visit 2 of SP743 (NCT00238524) or SP874 (NCT00350103)
• Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =3 times the upper limit of the normal range (ULN) with total bilirubin =2 times ULN or transaminases (AST and/or ALT) =5 times ULN
• Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial
• Subject is a pregnant or nursing female, or is of childbearing potential and is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Neuropathy

Intervention

Drug:
• Lacosamide
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years

Locations

Country	Name	City	State
Austria	180	Wien
Austria	183	Wien
Belgium	003	Antwerp
Belgium	006	Bonheiden
Belgium	002	Genk
Belgium	001	Leuven
Belgium	005	Merksem
Belgium	004	Roeselare
Bulgaria	011	Pleven
Bulgaria	014	Plovdiv
Bulgaria	017	Plovdiv
Bulgaria	019	Ruse
Bulgaria	012	Sofia
Bulgaria	013	Sofia
Bulgaria	015	Sofia
Bulgaria	016	Sofia
Bulgaria	210	Stara Zagora
Bulgaria	010	Varna
Czechia	028	Brno
Czechia	220	Chomutov
Czechia	026	Litomerice
Czechia	027	Olomouc
Czechia	024	Ostrava-Poruba
Czechia	029	Pisek
Czechia	021	Praha 1
Czechia	022	Praha 5
Finland	192	Kuopio
France	034	Lisieux
France	031	Nevers
Germany	040	Bad Saarow
Germany	052	Beckum
Germany	049	Berlin
Germany	051	Berlin
Germany	056	Berlin
Germany	242	Berlin
Germany	249	Berlin
Germany	247	Bochum
Germany	041	Hamburg
Germany	045	Hamburg
Germany	054	Hamburg
Germany	244	Jena
Germany	058	Köthen
Germany	043	Künzing
Germany	050	Leipzig
Germany	053	Leipzig
Germany	250	Leipzig
Germany	046	Mittweida
Germany	243	München
Germany	246	Schwerin
Germany	044	Stuhr-Brinkum
Germany	248	Witten
Hungary	060	Budapest
Hungary	062	Budapest
Hungary	061	Gyor
Hungary	262	Kecskemét
Hungary	260	Makó
Hungary	266	Nyíregyháza
Hungary	064	Szeged
Hungary	265	Székesfehérvár
Hungary	264	Szolnok
Hungary	263	Tatabánya
Hungary	261	Veszprém
Italy	270	Pavia
Italy	273	Pavia
Italy	272	Pozzilli
Poland	092	Bialystok
Poland	293	Bialystok
Poland	094	Bydgoszcz
Poland	095	Czestochowa
Poland	091	Gdansk
Poland	093	Gdansk
Poland	294	Kraków
Poland	297	Kraków
Poland	090	Lodz
Poland	295	Lodz
Poland	291	Radom
Poland	292	Warszawa
Poland	296	Warszawa
Poland	290	Zabkowicki
Romania	100	Bucharest
Romania	102	Bucharest
Romania	107	Bucharest
Romania	108	Bucharest
Romania	109	Bucharest
Romania	101	Cluj-Napoca
Romania	103	Timisoara
Russian Federation	114	Moscow
Russian Federation	115	Moscow
Russian Federation	116	Moscow
Russian Federation	111	Samara
Russian Federation	112	St. Petersburg
Serbia	140	Belgrade
Serbia	143	Belgrade
Serbia	144	Belgrade
Serbia	142	Nis
Spain	137	Granada
United Kingdom	159	Bath
United Kingdom	154	Bristol
United Kingdom	152	Leeds
United Kingdom	150	Morriston
United Kingdom	151	Newport

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Austria,  Belgium,  Bulgaria,  Czechia,  Finland,  France,  Germany,  Hungary,  Italy,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.	From entry Visit 1 through end of treatment (approximately 6.5 years)
Primary	Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).	A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Is fatal; Is life-threatening; Results in persistent or significant disability/incapacity; Requires inpatient hospitalization; Prolongs existing inpatient hospitalization; Is a congenital anomaly/birth defect; Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above	From entry Visit 1 through end of treatment (approximately 6.5 years)
Secondary	Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.	On the Likert Scale, 0 = no pain and 10 = worst possible pain.	Baseline
Secondary	Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.	On the Likert Scale, 0 = no pain and 10 = worst possible pain.	Last Visit (approximately 2 years)
Secondary	Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.	Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.	Baseline
Secondary	Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.	On VAS 0 mm = no pain and 100 mm = worst possible pain.	Last Visit (approximately 2 years)
Secondary	Patient's Global Impression of Change (PGIC) at Last Visit.	The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).; Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).	Last Visit (approximately 2 years)
Secondary	Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit.	0 = no pain and 10 = most intense pain sensation imaginable.	Baseline Visit; Last Visit (approximately 2 years)
Secondary	Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit.	0 = not sharp and 10 = most sharp sensation imaginable.	Baseline Visit; Last Visit (approximately 2 years)
Secondary	Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit.	0 = not hot and 10 = the most hot sensation imaginable.	Baseline Visit; Last Visit (approximately 2 years)
Secondary	Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit.	0 = not cold and 10 = the coldest sensation imaginable.	Baseline Visit; Last Visit (approximately 2 years)
Secondary	Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit.	0 = not dull and 10 = most dull sensation imaginable.	Baseline Visit; Last Visit (approximately 2 years)
Secondary	Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit.	0 = not unpleasant and 10 = most unpleasant sensation imaginable.	Baseline Visit; Last Visit (approximately 2 years)
Secondary	Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit.	0 = no surface pain and 10 = most intense surface pain imaginable.	Baseline Visit; Last Visit (approximately 2 years)
Secondary	Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit.	0 = no deep pain and 10 = most intense deep pain imaginable.	Baseline Visit; Last Visit (approximately 2 years)
Secondary	Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit.	0 = not itchy and 10 = most itchy sensation imaginable.	Baseline Visit; Last Visit (approximately 2 years)
Secondary	Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit.	0 = not sensitive and 10 = most sensitive sensation imaginable.	Baseline Visit; Last Visit (approximately 2 years)
Secondary	Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.	0 = no interference with sleep and 10 = worst possible interference with sleep.	Baseline
Secondary	Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.	0 = no interference with sleep and 10 = worst possible interference with sleep.	Last Visit
Secondary	Average Pain Interference With Activity (11-point Likert Scale) at Baseline.	0 = no interference with activity and 10 = worst possible interference with activity.	Baseline
Secondary	Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.	0 = no interference with activity and 10 = worst possible interference with activity.	Last Visit
Secondary	Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline.	The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.	Baseline
Secondary	Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit.	The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.	Last Visit
Secondary	Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline.	The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.	Baseline
Secondary	Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit.	The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.	Last Visit