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Clinical trials are used to determine the effectiveness and safety of new treatments. These clinical trials allow patients to engage and contribute to medical research. Participation requires learning as much as possible about the drug and carefully following study guidelines. There may be risks involved with any treatment. If you would like general information about clinical trials, click here.
NTI 0302 – for patients needing Decadron® to manage acute and worsening symptoms (0302 study is now closed to enrolment)
If you decide to participate in this study, you will be assigned to one of two groups of people. One group of people will receive the investigational drug. (XERECEPT). The other group of people will receive a placebo.
Patients who receive the placebo will also be given 4 mg of Decadron in addition to Decadron they are already taking.
A computer will decide who enters which group. Neither you or your doctor will be able to know which group you have been assigned to.
If you decide to participate in this study, you will also:
- Continue to take any Decadron you are already taking
- Make 7 visits over 12 weeks to your study doctor for study evaluations
If you have any questions regarding this information, please see the list of study locations on this website and contact the clinic most convenient to you.
NTI 0303 – for patients taking Decadron* on a long-term basis (0303 study is now closed to enrolment)
If you decide to participate in this study, you will be assigned to one of two groups of people. One group of people will receive the investigational drug. (XERECEPT). The other group of people will receive a placebo.
A computer will decide who enters which group. Neither you nor your doctor will know which group you have been assigned to.
If you decide to participate in this study, you will also:
- Continue your Decadron, but gradually reduce your dose by 50% or more
- Make 8 visits over 16 weeks to your study doctor for study evaluations
- Record your doses of study drug and Decadron on a daily basis
If you have any questions regarding this information, please see the list of study locations on this website and contact the clinic most convenient to you.
NTI 0501 – open-label study for patients who have already participated in NTI 0302 or NTI 0303
This Phase III study allows for patients to receive open-label XERECEPT for an indefinite period of time after participating in study NTI 0302 or NTI 0303 and completing the required follow-up visits for those studies.
If you participate in this study, you will:
- Make a Baseline visit to your study physician for physical and neurological evaluations
- Make monthly visits to your study physician for as long as you are in the study
- If you stop taking XERECEPT before the study is finished, make a visit to your study physician for physical and neurological evaluations and return 4 weeks after your last dose of XERECEPT for a final follow-up visit
If you have any questions regarding this information, please see the list of study locations on this website and contact the clinic most convenient to you.
*Decadron is a registered trademark of Merck & Co., Inc. |
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