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pramipexol · 1 trial · 1 indication
International Restless Legs Syndrome Study Group Rating Scale (IRLS) is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.
IRLS is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Responders were defined as participants who report CGI-I score of "very much improved" or "much improved".
Augmentation was worsening of RLS symptoms, attributable to a specific long-term therapeutic intervention for RLS. Percentage of participants with augmentation was evaluated by centralized evaluation board using a set of assessment criteria for potential augmentation which included structured interview for diagnosis of augmentation during RLS treatment (SIDA-RLS), augmentation severity rating scale (ASRS), clinical judgment. ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.
| Arm | Type | Description |
|---|---|---|
| PBO/PGB 300 mg | EXPERIMENTAL | - |
| PBO/PPX 0.25 mg | ACTIVE_COMPARATOR | - |
| PBO/PPX 0.5 mg | ACTIVE_COMPARATOR | - |
| PGB 300 mg | EXPERIMENTAL | - |
| PPX 0.25 mg | ACTIVE_COMPARATOR | - |
| PPX 0.5 mg | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| placebo and pregabalin | DRUG | following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime. |
| pramipexol | DRUG | following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime. |
| Pregabalin | DRUG | pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months |
Inclusion Criteria: * idiopathic RLS with the presence of all four clinical manifestations of RLS * RLS symptoms occur predominantly in the evening * RLS history at least 6 months * IRLS =\> 15 at the beginning and the end of placebo run-in * Have =\>15 nights with RLS symptoms in the month prior t...
Pramipexol is used for the treatment of idiopathic Restless Legs Syndrome, a condition characterized by an uncontrollable urge to move the legs, typically accompanied by uncomfortable sensations. It is being studied as a small molecule therapy for this indication in a Phase 3 clinical trial.
Pramipexol is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research to evaluate the drug's safety and efficacy for idiopathic Restless Legs Syndrome.
Pramipexol is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial is designed to assess its long-term effects in patients with idiopathic Restless Legs Syndrome.
Pramipexol is being evaluated in a Phase 3 clinical trial registered as NCT00806026, titled "Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients." This completed study enrolled 731 participants across multiple countries, including the United States, Austria, Finland, Germany, Italy, Netherlands, Spain, Sweden, and the United Kingdom.
Pramipexol is not the same as pregabalin. The clinical trial NCT00806026, which studies pramipexol, is titled "Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients," but pramipexol is a distinct drug. The trial may compare or combine these agents, but they are separate compounds.
Pramipexol works by acting as a dopamine agonist, stimulating dopamine receptors in the brain to help regulate nerve signals that contribute to Restless Legs Syndrome symptoms. This mechanism is believed to reduce the urge to move and improve sleep quality in affected individuals.