Melatonin in Patients With Multiple Sclerosis (MS).
Parole chiave
Astratto
Descrizione
The primary objective of this study is to evaluate the change in 24 hour urinary 6-sulfatoxymelatonin (6SMT) collected for 24 hours in two twelve hour sessions. The secondary objectives are to evaluate the change in serum morning melatonin level. In addition, quality of life (QOL) measures will be assessed including the Modified Fatigue Impact Scale (MFIS), Multiple Sclerosis Impact Scale (MSIS-29), and the Pittsburgh Sleep Quality Index (PSQI). Clinical objectives include the number of relapses during the trial and a change in the Patient Determined Disease Steps (PDDS) & Performance Scales (PS).
The pilot study is a one-year randomized, rater- and dose-blinded trial evaluating the potential role of melatonin in subjects with relapsing multiple sclerosis who have been taking a stable dose of an oral disease modifying therapy (DMT) for at least 6 months. The oral DMTs include dimethyl fumarate, fingolimod, and teriflunomide. Thirty subjects with relapsing forms of multiple sclerosis who meet all of the eligibility criteria will be enrolled at Providence Neurological Specialties in Portland, Oregon.
Date
| Ultimo verificato: | 08/31/2019 |
| Primo inviato: | 04/05/2018 |
| Iscrizione stimata inviata: | 04/05/2018 |
| Primo pubblicato: | 04/12/2018 |
| Ultimo aggiornamento inviato: | 09/24/2019 |
| Ultimo aggiornamento pubblicato: | 09/25/2019 |
| Data di inizio effettiva dello studio: | 05/08/2018 |
| Data di completamento primaria stimata: | 02/28/2021 |
| Data stimata di completamento dello studio: | 02/28/2022 |
Condizione o malattia
Intervento / trattamento
Drug: 3 mg Melatonin
Drug: 5 mg Melatonin
Fase
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| Experimental: 3 mg Melatonin Subjects will receive 3 mg melatonin once a day. | Drug: 3 mg Melatonin 3 mg melatonin once each day |
| Experimental: 5 mg Melatonin Subjects will receive 5 mg melatonin once a day. | Drug: 5 mg Melatonin 5 mg Melatonin once each day |
Criteri di idoneità
| Età idonea per lo studio | 18 Years Per 18 Years |
| Sessi idonei allo studio | All |
| Accetta volontari sani | sì |
| Criteri | Inclusion Criteria: - Male and female subjects with relapsing forms of MS who have been on a stable dose of dimethyl fumarate, fingolimod, or teriflunomide for 6 months or longer - Confirmed diagnosis of Relapsing MS - Women of childbearing potential must employ proven methods to prevent pregnancy during the course of the trial; the acceptable method will be left to the judgment of the investigator - Not pregnant or lactating - No evidence of significant cognitive or psychiatric disorder - Able to understand the purpose and risks of the study - Must be willing to sign an informed consent and follow the protocol requirements Exclusion Criteria: - Use of melatonin within 30 days of enrollment - The addition of any sleep aide or change in dose within 30 days of enrollment or during the trial - The addition or change in dose of Vitamin D within 30 days of enrollment or during the trial - Change in disease modifying therapy (DMT) during the trial - Steroid therapy within 30 days of enrollment - Use of anticoagulation at the time of enrollment and during the trial - The addition or change in dose of any stimulants, including but not limited to, amantadine, armodafinil, methylphenidate, or modafinil within 30 days of enrollment or during the trial |
Risultato
Misure di esito primarie
1. Changes in urine melatonin levels [3, 6, and 12 months]
Misure di esito secondarie
1. Modified Fatigue Impact Scale (MFIS) [3, 6, and 12 months]
2. Serum melatonin level [3, 6, and 12 months]
3. Multiple Sclerosis Impact Scale-29 (MSIS-29) [3, 6, and 12 months]
4. Pittsburgh Sleep Quality Index (PSQI) [3, 6, and 12 months]
5. Relapse Rate [12 months]
6. Patient Determined Disease Steps - Performance Scale (PDDS-PS) [3, 6, and 12 months]
