Primary Fibromyalgia Clinical Trial
Official title:
Cross-over Multiple Dose Study Assessing the Analgesic Efficacy and Safety of Oral GRT9906 Compared to Placebo in Subjects With Primary Fibromyalgia Syndrome
The study was performed in participants suffering from fibromyalgia and investigated efficacy after treatment with several doses of GRT9906 versus placebo. Furthermore, it was to be found out if treatment with GRT9906 was safe and well-tolerated.
This Phase 2 study had a randomized, multi-center, double-blind, placebo-controlled,
crossover, multiple-administration design.
The objectives of the study were the following:
- To assess the multiple-dose analgesic efficacy and safety of an oral prolonged-release
(PR) tablet formulation of GRT9906 at daily doses between 80 and 240 milligrams (mg) in
comparison to placebo in participants with moderate to severe pain due to primary
fibromyalgia syndrome (FMS).
- To compare the tolerability of multiple-dose GRT9906 PR to placebo in participants with
primary FMS.
- To generate data that could be used, in combination with data from other studies, to
explore the population pharmacokinetic analysis and pharmacokinetic/pharmacodynamic
(PK/PD) properties of GRT9906 PR.
The study consisted of 5 phases:
1. Enrollment including tapering, if necessary, and washout (at least 1 week) of previous
medication.
2. First treatment period with 1-week titration and 5-weeks dosing on participant's last
well-tolerated titration dosage.
3. Interim washout period of at least 1 week.
4. Second treatment period with 1-week titration and 5-weeks dosing on participant's last
well-tolerated titration dosage.
5. Final washout period of at least 1 week, terminated by a Follow-up Visit.
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