Trials / Terminated
TerminatedNCT03387046
A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)
Evaluation of clINical reCovery After a Relapse: a Pilot Study assEssing the Neuronal Effects of D-Aspartate in RR-MS Subjects Treated With IntErferon Beta 1a 44 mcg TIW (INCREASE)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to evaluate the improvement in spontaneous recovery from clinical deficits at the time of an acute relapse in RR-MS participants already receiving interferon (IFN) beta 1a with D-aspartate (versus placebo) as add-on therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | D-aspartate | D-aspartate 2660 milligram (mg) once daily in the form of oral solution for 24 weeks. |
| DRUG | Placebo | Placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks. |
| BIOLOGICAL | IFN beta-1a | IFN beta-1a was administered subcutaneously at a dose of 44 microgram (mcg) three times a week for 24 weeks. |
| DRUG | Methylprednisolone | Methylprednisolone 1000 mg was administered intravenously once daily for 5 consecutive days. |
Timeline
- Start date
- 2018-03-26
- Primary completion
- 2019-01-11
- Completion
- 2019-01-11
- First posted
- 2017-12-29
- Last updated
- 2020-02-10
- Results posted
- 2020-02-10
Locations
17 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT03387046. Inclusion in this directory is not an endorsement.